Drugdu.com expert's response:

 

I. Preliminary Preparation: Clarify Classification and Regulatory Foundations

1. Product Classification

According to Annex VIII of the IVDR Regulation (EU 2017/746), in vitro diagnostic devices are categorized into four risk classes: A, B, C, and D:

Class A: Low risk (e.g., general laboratory reagents). Non-sterile Class A devices can be self-declared, while sterile Class A devices require notified body involvement.

Class B: Medium-low risk (e.g., pregnancy test kits). Requires notified body review of technical documentation and quality management system (QMS).

Class C: Medium-high risk (e.g., tumor marker tests). Requires comprehensive notified body review.

Class D: High risk (e.g., HIV or HCV tests). Subject to the strictest review, including performance evaluation and clinical data.

2. Regulations and Standards

Core Regulation: IVDR (EU 2017/746) and its accompanying guidelines.

Harmonized Standards: ISO 13485 (QMS), ISO 14971 (risk management).

Unique Device Identification (UDI): Must be registered in the EUDAMED database and labeled on the device.

II. Key Steps: Systematic Operational Process

1. Establish a Quality Management System (QMS)

Basis: ISO 13485, covering design, development, production, and post-market processes.

Key Requirements:

Risk management files must comply with ISO 14971, addressing risk analysis, control, and residual risk assessment.

Production environments must meet cleanliness standards (e.g., Class 100,000/10,000 cleanrooms).

Supplier management: Ensure authenticity of raw material suppliers and complete confidentiality agreements.

2. Prepare Technical Documentation

Core Content:

Product Description and Specifications: Include intended use, structural composition, and operating principles.

Performance Evaluation Report: Cover sensitivity, specificity, accuracy, and other key metrics, supported by laboratory test data.

Clinical Evaluation: Design clinical protocols based on risk class, collect real-world data, and compare against existing standards or controls.

Biological Evaluation: Assess material biocompatibility to ensure no toxicity or sensitization.

Format Requirements: Comply with Annexes II and III of IVDR, using A4 paper with a left margin >20mm, clear copies, and official stamps.

3. Select a Notified Body

Qualification Verification: Confirm the body’s IVDR certification资质 (competence) via the EU Notified Bodies List.

Key Communication Points:

Clarify product classification and applicable conformity assessment routes (e.g., Annexes IX, X, or XI).

Confirm review scope covers special scenarios like self-testing or companion diagnostics.

Discuss review timelines and costs to avoid escalations due to outsourcing or multi-site production.

4. Submit Application and Undergo Review

Pre-Application Questionnaire: Complete and submit with corporate information and supply chain details.

Preliminary Check: Notified body verifies corporate credibility, EUDAMED registration, and certification feasibility.

Contract Signing: After accepting a non-binding quote, sign a legally binding contract outlining review scope and schedule.

Review Stages:

Stage 1 Audit: Assess QMS compliance with IVDR, focusing on design/development and risk management processes.

Stage 2 Audit: Review technical documentation, including performance evaluations, clinical data, and labeling.

On-Site Audit: May conduct unannounced inspections of production facilities, equipment, and records.

5. Address Non-Conformities and Obtain Certification

Non-Conformity Handling: Submit a corrective action plan within 30 working days to resolve issues and close non-conformities.

Certificate Issuance: Upon successful review, the notified body issues an EU Quality Management System Certificate and (if applicable) an EU Technical Documentation Assessment Certificate.

III. Ongoing Compliance: Post-Market Surveillance and Updates

1. Annual Surveillance Audits

Class B, C, and D devices require annual notified body audits to ensure continued QMS effectiveness.

2. Technical Documentation Updates

Regularly revise performance evaluation reports and clinical data based on market feedback, technological advancements, or regulatory changes.

3. Post-Market Surveillance (PMS)

Establish a PMS plan to collect user feedback and adverse event reports.

Conduct Post-Market Performance Follow-Up (PMPF) for long-term monitoring of high-risk devices.

4. EUDAMED Registration

Register products and UDIs in the EU医疗器械 database (EU Medical Device Database) to ensure traceability.

IV. Efficiency Strategies: Mitigate Common Risks

1. Early Classification Confirmation

Avoid project delays or redundant reviews by confirming classification accurately upfront.

2. Proactive Compliance Integration

Embed IVDR requirements during R&D to minimize late-stage rectification costs.

3. Dedicated Team Support

Appoint a compliance officer and ensure technical staff are trained in regulations and review processes.

4. Dynamic Policy Monitoring

Track IVDR amendments (e.g., new classifications for AI-assisted diagnostics) and adjust strategies promptly.

By editor